Kornimate/medical-research-clean huggingface dataset:
systemic sclerosis (ssc) vasculopathy: improved clinical monitoring and treatment

Conditions: Rheumatologic Disease

Summary: systemic sclerosis (ssc; scleroderma) is a multi-organ systemic disease characterized by activation of immune cells, which results in vascular dysfunction (vasculopathy) and subsequent scarring (fibrosis). ssc has a higher than expect prevalence in the us military. on a national level there are 5,766 ssc patients (icd-9 710.1) presently cared for in the veterans health administration (vha). while there is no cure for ssc, studies of therapeutics that can help slow disease progression are valuable to our veterans. this proposal addresses the solicitation for projects with attention to ssc requested by president obama after reviewing potential contamination of water at camp lejeune. this proposal is a patient-centered outreach for our veterans with ssc to inform and prevent catastrophic endstage vascular abnormalities, including digital ulcers, pulmonary arterial hypertension (pah) and scleroderma renal crisis in ssc. the study proposes a novel application of a therapeutic for this disease. a better understanding of the initiating insult and natural progression of ssc vasculopathy is needed in order to develop therapeutics with a goal of curing/treating the underlying disease. this project has the potential to impact not only veterans with ssc, but also those with vascular abnormalities including digital ulcers, pah, and renal crisis. this proposal represents a potential major therapeutic advance for our veterans with ssc.

although ssc is heterogeneous in the extent of organ involvement and prognosis, it is accepted that all ssc cases have a progressive and usually devastating course. since vasculopathy precedes fibrosis in this disease, a focus on understanding its natural history and preventative measures for vascular dysfunction has profound implications. this pilot work suggests that measurement of endothelial dysfunction with flow mediated dilatation (fmd) holds promise as novel method to assess disease progression as well as the therapeutic efficacy of the pharmacologic compound tetrahydrobiopterin (bh4) in ssc. the investigators believe that bh4, which targets the endothelium, has great promise to reduce ssc-related tissue hypoxia, end organ damage, and potentially may impact underlying disease progression. the first aim will adopt an integrative approach and validate a novel, non-invasive technique, fmd to define vasculopathy in ssc. the second aim and third aim (which is reported in this prs report) will examine if bh4 is effective in ameliorating vascular dysfunction in patients with ssc and determine the role of oxidative stress in bh4-mediated improvements in vascular function in patients with ssc. the overarching goal of these aims is to improve vasculopathy detection and management in veterans with ssc.

Eligibility criteria:
inclusion criteria: * diagnosis of systemic sclerosis (ssc, scleroderma) by acr/eular 2013 criteria. exclusion criteria: * age \< 18 * pregnant or breast feeding * unwillingness to consent
analgesic effect of rtms in vasculitic neuropathy

Conditions: Vasculitic Neuropathy

Summary: vasculitic neuropathy (vn) results from inflammation and destruction of the walls of predominantly small vessels with subsequent ischemic damage of peripheral nerves. vn is painful in vast majority of patients and the pain is intractable with pharmacotherapy in about 40% of cases. repetitive transcranial magnetic stimulation (rtms) is a noninvasive method of modulation of brain plasticity and is regarded as one of alternative methods to alleviate pain associated with various kind of neuropathies. the purpose of this study is to compare the effectiveness of analgesic effect of rtms in vasculitic neuropathy with sham stimulation.

vasculitic neuropathies (vn) are a group of disorders resulting from inflammation of predominantly small vessels with destruction of their walls and subsequent ischemic damage of peripheral nerves. neural damage may or may not coexist with the damage of other organs. examples of conditions associated with vn include diabetes, microscopic polyangiitis, eosinophilic granulomatosis with polyangiitis (churg-strauss), granulomatosis with polyangiitis (wegener's), rheumatoid arthritis, systemic lupus erythematosus and others. vn is painful in about 80% of patients of whom 40% suffer from the pain intractable with pharmacological therapy. repetitive transcranial magnetic stimulation (rtms) is a noninvasive method of modulation of brain plasticity. in this method, series of magnetic stimuli are delivered to the cerebral cortex, where they turn to electric current and depolarize repetitively the targeted neurons. if the stimulation is repeated during subsequent days it is capable to modify the activity of targeted cortical area for weeks or even months and by this way to achieve therapeutic effect. rtms is widely regarded as one of alternative methods to alleviate pain associated with various kind of neuropathies. the purpose of this study is to compare the effectiveness of analgesic effect of rtms in vasculitic neuropathy with sham stimulation.

Eligibility criteria:
inclusion criteria: * diagnosis of vasculitic neuropathy * neuropathic pain of constant severity since not less than a month and requiring use of analgesics more than once a week * score of 30 milimeter or more on the 100 milimeter visual analog scale of pain intensity at inclusion exclusion criteria: * severe depression * personality disorders and other psychiatric conditions, which could disturb the participation in the study * cognitive deficits, which could disturb the participation in the study * contraindications for rtms as listed by the guidelines of the international federation of clinical neurophysiology (rossi et al. 2009) i.e. seizure in the past, epilepsy, presence of magnetic material in the reach of magnetic field, pregnancy, likelihood to get pregnant, intracranial electrodes, cardiac pacemaker or intracardiac lines, frequent syncopes

Keywords: vasculitis neuropathy pain transcranial magnetic stimulation analgesic effect
a trial comparing transversus abdominis plane catheter versus epidural after esophagectomy

Conditions: Esophageal Cancer; Pain, Postoperative

Summary: a randomized trial comparing perioperative outcomes between bilateral transversus abdominis plane tap catheters with patient controlled analgesia (pca) to epidural for esophagectomy patients with a vats chest approach. further objectives are to determine pain requirements between multiple modalities of pain control and compare the subsequent sequelae of narcotic use and blood pressure control and to compare complications such as anastomotic leak, atrial fibrillation and perioperative morbidity and mortality between the two groups.

epidural analgesia is considered the 'gold standard' for post-operative analgesia following open esophagectomy. epidurals have been shown to reduce post-operative pulmonary morbidity and mortality. however, epidurals are often associated with sympathetic blockade that creates hypotension and could therefore adversely affect the conduit. pain management techniques that use peripheral nerve blockade are becoming more prevalent, reducing the need for an epidural. transversus abdominis plane (tap) catheters have been used in colorectal and abdominal surgery showing equivocal pain scores to epidurals. with the minimally invasive chest approach, the analgesia coverage focuses on the abdominal incision where both epidurals and taps are considered standard of care. the investigators have completed a retrospective study in preparation for a randomized control trial. the investigators previous retrospective study found that tap blocks/catheters are a reasonable alternative to epidurals, providing adequate pain coverage for abdominal incisions. the study found no statistical difference in pain scores between the two groups. the tap group had a lower prevalence of hypotension and lower crystalloid resuscitation needs. pulmonary complications were similar between the two groups. this retrospective review showed that tap blocks are a reasonable alternative to epidurals and may reduce episodes of hypotension. the investigators aim is to now expand this study to a randomized control trial.

Eligibility criteria:
inclusion criteria: * all adult individuals who undergo an esophagectomy with a minimally invasive approach of the chest at swedish medical center-first hill. these approaches include: * 3 hole with r video-assisted thoracoscopic surgery (vats) * ivor lewis r vats * transhiatal exclusion criteria: * age \<18 * unable to consent * additional surgical procedures planned * patient with chronic pain on a daily regimen of narcotics * patients who remain intubated greater than 24 hours post operatively * non-english speaking

Keywords: esophageal cancer transversus abdominis plane catheter epidural pain, postoperative
a study to investigate the efficacy and safety of sonrotoclax plus zanubrutinib compared with placebo plus zanubrutinib in adults with relapsed/refractory mantle cell lymphoma

Conditions: Mantle Cell Lymphoma; B Cell Lymphoma

Summary: the goal of this study is to compare how well sonrotoclax plus zanubrutinib works versus zanubrutinib plus placebo in treating adults with relapsed/refractory (r/r) mantle cell lymphoma (mcl). this study will also look at the safety of sonrotoclax plus zanubrutinib versus zanubrutinib plus placebo.


Eligibility criteria:
inclusion criteria: * histologically confirmed diagnosis of mcl based on the world health organization 2022 classification of haematolymphoid tumors (who-haem5), or based on international consensus classification (icc) * received 1 to 5 prior lines of systemic therapy including an anti-cd20 monoclonal antibody (mab)-based immunotherapy or chemoimmunotherapy and requiring treatment in the opinion of the investigator * relapsed or refractory disease after the last line of therapy * measurable disease defined as ≥ 1 nodal lesion that is \> 1.5 cm in longest diameter, or ≥ 1 extranodal lesion that is \> 1 cm in longest diameter * eastern cooperative oncology group (ecog) performance status of 0 to 2 * adequate organ function exclusion criteria: * prior therapy with b-cell lymphoma-2 inhibitor * prior therapy with covalent or non-covalent bruton tyrosine kinase inhibitor (btki) unless the participant was intolerant of non-zanubrutinib covalent or non-covalent btki * prior autologous stem cell transplantation or chimeric antigen receptor t-cell therapy within 3 months before first dose of study drug * prior allogeneic stem cell transplant within 6 months of the first dose of the study drug * known central nervous system involvement by lymphoma * clinically significant cardiovascular disease * history of stroke or intracranial hemorrhage within 6 months before first dose of study drug note: other protocol defined inclusion/exclusion criteria may apply.

Keywords: mantle cell lymphoma mcl relapsed/refractory mantle cell lymphoma sonrotoclax
effectiveness of bethanechol chloride and early bladder training for prevention of bladder dysfunction after radical hysterectomy in cervical cancer stage ib - iia

Conditions: Bladder Dysfunction

Summary: compare the effectiveness of bethanechol chloride and early bladder training for prevention of bladder dysfunction after radical hysterectomy in cervical cancer stage ib - iia.

cervical cancer is the third most common cancer in women worldwide, after breast and colorectal cancer. molecular biology has firmly established a causal relationship between persistent infection with high risk human papilloma virus (hpv) genotypes and cervical cancer. cervical cancer stage ib1 and selected iia 1 lesions without extensive vaginal involvement can be treated with either rh and pelvic lymph node dissection (pld) or primary chemoradiation. bladder dysfunction is the most common complication after radical hysterectomy. the incidence is approximate 10-80 %. management of bladder dysfunction is continuous urethral catheterization or clean intermittent self-catheterization. prolonged urethral catheterization may increase the risk of urinary tract infection. early postoperative bladder training that consist of a scheduled clamping trans-urethral catheter every 3 h and unclamping trans-urethral catheter 15 min during the entire day. bethanechol chloride is a cholinergic drug and may enhance the detrusor muscle contraction, resulting in higher maximum flow rate, and lower postvoid residual urine. this study was conducted to compare the effectiveness of bethanechol chloride and early bladder training for prevention of bladder dysfunction after radical hysterectomy in cervical cancer stage ib - iia.

Eligibility criteria:
inclusion criteria: * women with cervical cancer stage ib - iia underwent standard type iii radical hysterectomy, both open and laparoscopic approach * patient aged 20 - 65 years * patient able to give free and informed consent and who agrees to participate be signing the consent form exclusion criteria: * patient who had an allergic reaction to bethanechol chloride * patient who had neurogenic bladder
calcium (ca),phosphorus( p) and 25-hydroxyvitamin d(25ohd)] in infants born ≤ 32 pma gestational weeks (ga)

Conditions: Infant, Premature, Diseases

Summary: it has not yet been established the optimal dose of vit. d for preterm infants in poland. it is not known what dose of vit. d will provide the correct concentration of vit. d and the optimal development of the skeleton of the premature. the study will try to determine the optimal supplementation of vitamin d and the supply of ca and p for normal growth and development of a child born prematurely. in addition, the investigators will evaluate any risk factors for deficiency and excess of vitamin d and the consequences of its deficiency and overdose. simultaneously the study would make possible the determination of an optimal schedule for controlling the ca-p levels in the group of the youngest infants born prematurely. in addition, the study will assess the relationship between maternal and newborn vitamin d resources right after birth, and the incidence of vitamin d deficiency in infants born prematurely. preterm infants will be randomized in 3 groups assigned to different doses of vit. d. the study will investigate the metabolism of calcium, phosphorus, the health of bones and development of the premature babies till the age of 2.

the participants of the study will be prematures, born ≤32 ga, hospitalized in the department of neonatology, in the neonatal intensive care unit. hospitalized patients who meet the inclusion criteria will be randomized in 3 groups assigned to different doses of vit. d (400, 800 or 1200 units(unt) of vitamin d). at defined age points of postnatal life, parameters of calcium and phosphorus metabolism and vitamin d level will be tested, along with the health of bones, health status and development.

Eligibility criteria:
inclusion criteria: * gestational age ≤32 weeks at birth * hospitalization in the department no later than at the age of 7 days (for infants born outside the center) * no birth defects or diseases permanently affecting the ability to accept enteral feeding * anticipated possibility of continuous monitoring of the course of treatment in hospital until discharge * consent of parents / legal guardians for the participation in the study. exclusion criteria * gestational age\> 32 weeks at birth * the beginning of hospitalization in the department later than the age of 7 days (for infants born outside the center) * presence of congenital defects or diseases permanently affecting the ability to accept enteral feeding (e.g.oesophageal atresia, anal atresia, congenital umbilical hernia, gastroschisis, syndromes genetically determined) * significant interruption (\> 1 week) of the hospitalization in the center * lack of consent of the parents / legal guardians to participation in the study

Keywords: premature osteopenia vit. d lbw (low birth weight) 25ohd
bibloc mandibular advancement oral device and its effect on tmj health

Conditions: Obstructive Sleep Apnea of Adult

Summary: the goal of this clinical trial is to learn if mandibular advancement device( mad) works to treat obstructive sleep apnea in adults. it will also learn about the effect of the device on the tempromandibular joint health . the main questions it aims to answer are: does mad lower the number of apnoea and hypopnea participants suffer from during sleep? would it cause any effect on tmj health? researchers will compare between a group of tmd patients with osa to a non_tmd group of patients also with sleep apnea and both groups will receive a bibloc madplacebo (a look-alike substance that contains no drug) to see if it affect the tmj health. participants will: wear mad during sleep (at least 6 hours) every day for 6 months visit the clinic once after the first week for checkups and adjustment of mad if needed and then after 3 months and 6 months. polysomnography, mri, and tmd screening was done before the appliance insertion and after 6 months of its insertion.


Eligibility criteria:
inclusion criteria: - patients having obstructive sleep apnea syndrome (osas) as determined by polysomnography with mild to moderate apnea/hypopnea index ranging from 5 to 30 events per hour of sleep. ( as 5-15 events per hour is considered mild condition, 16-30 is considered moderate).(1) 2- adequate nasal air flow capacity as determined by qualified otolaryngologist. exclusion criteria: * patients having central sleep apnea events as determined by the polysomnography. 2- patients having cardiovascular disease. 3- history of alcohol, narcotic or psychoactive medications. 4- serious nasal passage obstructions or allergies. 5- previous history of treatment with any type of obstructive sleep apnea oral appliances. 6- obese patients with bmi more than 30. 7- missing more than five teeth (excluding third molar). 8- allergy to acrylic resin.
alterations in connective tissue in patients with or without pelvic organ prolapse

Conditions: Pelvic Organ Prolapse

Summary: the aim of our study is to investigate the alterations in connective tissue of vaginal wall in patients with and without pelvic organ prolapse (pop).

the tissue samples were taken from the anterior wall of vagina in the midline close to cervix or apex. the tissue samples were collected from the vaginal wall of the patients with pelvic organ prolapse (n=39) during vaginal prolapse surgery. control samples (n=39) were taken from patients after vaginal or laparoscopic removal of the uterus. the formalin-fixed and paraffin embedded tissue samples were stained with verhoeff van gieson and movat's pentachrome. samples were examined by pathologist and gynecologist blinded as to the other investigator and to the pelvic organ prolapse status. in case of discrepancy investigators evaluated the samples together to gain consensus.

Eligibility criteria:
inclusion criteria: * surgery for pelvic organ prolapse * hysterectomy due to other benign reasons than pelvic organ prolapse exclusion criteria: * surgery due to malignancy

Keywords: pelvic organ prolapse connective tissue elastin collagen
validation of a cognitive remediation program for bipolar disorders

Conditions: Bipolar Disorder

Summary: this study evaluates the effect of a new cognitive remediation program designed for patients suffering from a bipolar disorder, on cognitive functions, psychosocial functioning and neural processes. in this double-blind (patient, outcomes assessor) controlled randomized trial the investigators compare patients receiving the eco program for bipolar disorders, to patients benefiting from the broadly used cognitive remediation program crt and to patients receiving supportive psychotherapy. patients are treated for 3 months and monitored for 9 months.


Eligibility criteria:
inclusion criteria: 1. type i or type ii bipolar disorder diagnosis, according to dsm-iv-tr criteria 2. no manic or major depressive episode during the last three months 3. no or few residual depressive symptoms (hdrs-17 ≤ 12) 4. no or few residual manic symptoms (ymrs ≤ 8) 5. stable dose of medication for the last two months 6. cognitive complaint expressed by the patient and impairment observed by the patient's regular psychiatrist 7. informed consent form read, initialed and signed 8. patient registered on the social welfare system exclusion criteria: 1. other diagnosis than bipolar disorder on axis i of the dsm-iv-tr 2. rapid cycling bipolar disorder diagnosis 3. addiction or substance abuse (except tobacco) during the twelve last months 4. physical or neurological disorder that can lead to cognitive impairment 5. engagement in a research protocol either currently or over the last month 6. neuropsychological assessment or rorschach inkblot test evaluation during the last six months 7. ineligibility for magnetic resonance imaging \[mri\] (e.g. claustrophobia, metallic implants, pace-maker, etc.)

Keywords: cognitive remediation mood disorders neuropsychology
a trial of gc4419 in patients with critical illness due to covid-19

Conditions: Covid19; SARS-CoV-2 Infection

Summary: a trial of gc4419 in patients with critical illness due to covid-19


Eligibility criteria:
inclusion criteria: 1. male or female subjects at least 18 years of age. 2. ability to understand and the willingness to sign a written informed consent. 3. laboratory-confirmed sars-cov-2 infection as determined by a positive pcr test documented prior to randomization 4. requirement for intensive inpatient hospital care 5. acute hypoxemic respiratory failure typifying ards 6. adequate liver function 7. use of effective contraception exclusion criteria: 1. expected survival for less than 48 hours after randomization 2. child-pugh stage c hepatic impairment and/or portal hypertension secondary to cirrhosis 3. stage iv chronic kidney disease or end-stage kidney disease on maintenance hemodialysis 4. requirement for extra-corporeal membrane oxygenation (ecmo) 5. acute myocardial infarction (ami) 6. active bleeding requiring transfusion 7. concurrent participation in another clinical trial of experimental treatment for sarscov-2 8. female patients who are pregnant or breastfeeding 9. requirement for concurrent treatment with nitrates

Keywords: covid19 sars-cov-2 infection